BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2032994 · Received March 29, 2011

    Report

    Report Number
    2050012-2011-00907
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 26, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT INITIALLY RECOVERED TOO LOW. WHEN THEY WERE REPEATED, QC WAS WITHIN LAB-ESTABLISHED RANGES, BUT ON THE LOW END OF THE RANGE. SAMPLES WERE THEN RUN. AFTER THE EVENT, THE SYSTEM WAS RECALIBRATED AND THEN QC WAS WITHIN RANGE. RECALIBRATING THE SYSTEM SEEMED TO RESOLVE THE ISSUE. A BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE PERFORMED A "HEALTH CHECK" AND ALL TESTING PASSED SPECIFICATIONS AND NO ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING FALSE LOW SODIUM (NA) RESULTS FOR SIX (6) PATIENT SAMPLES THAT WERE GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. POTASSIUM (K) RESULTS WERE ALSO CONSIDERED LOW. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. WHEN A COMPUTER REPORT SHOWED THE TREND, THE SAMPLES WERE RERUN ON AN ALTERNATE INSTRUMENT IN THE LABORATORY AND RESULTS WERE AMENDED. ONE OF THE SIX PATIENTS IN THE ER WAS GIVEN A K SUPPLEMENT BASED UPON THE ORIGINAL K RESULT REPORTED. AFTER THE RESULT WAS AMENDED, THE PATIENT WAS SENT HOME AND THE PATIENT WAS NOT ADVERSELY IMPACTED BY THE TREATMENT. NO OTHER REPORTS WERE RECEIVED BASED ON PATIENT AFFECT FOR THIS EVENT. THIS REPORTABLE EVENT DOCUMENTS THE MALFUNCTION PORTION OF THIS EVENT. A SEPARATE MDR 2050012-2011-00908 DOCUMENTS THE AFFECT TO PATIENT TREATMENT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1